Enzychem Lifesciences Announces Database Lock for Phase 2 Study of EC-18 in Chemoradiation-Induced Oral Mucositis
ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–Enzychem Lifesciences (KOSDAQ: 183490), announced today database lock for the Phase 2 clinical trial of its lead program EC-18 in chemoradiation-induced oral mucositis (CRIOM) had been completed last August.
Enzychem will announce top-line results during October 2021. Enzychem received FDA Fast Track Designation for EC-18 in CRIOM and also plans to submit Breakthrough Therapy Designation (BTD) in 4Q 2021.
EC-18, the company’s lead investigational candidate, is a novel, first-in-class, oral immunomodulator, which facilitates rapid resolution of inflammation and early return to homeostasis.
“For patients treated with chemoradiation for head and neck cancer, oral mucositis is a debilitating side-effect which can cause treatment discontinuation,” said Dr. Stephen Sonis, a world-renowned expert in epithelial injury associated with cancer therapy and scientific advisory board member at Enzychem Lifesciences. “EC-18 has a unique mechanism of action which prevents excessive neutrophil recruitment to the inflamed sites and, thereby, lessens the severity of oral mucositis. Its oral delivery will be a much needed option for patients, as there are currently no FDA-approved therapies.”